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Anticonvulsants 治療 diabetic neuropathic pain 的效果. 小港醫院 R2 董錦松. 臨床問題. Anticonvulsants 對 diabetic neuropathic pain 的治療效果如何? 若 anticonvulsants 治療 diabetic neuropathic pain 有效,那一種 anticonvulsant 為最佳選擇?. 背景說明.

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slide2
臨床問題
  • Anticonvulsants對diabetic neuropathic pain的治療效果如何?
  • 若anticonvulsants治療diabetic neuropathic pain有效,那一種anticonvulsant為最佳選擇?
slide3
背景說明
  • 1960年代起,即開始使用anticonvulsants來治療neuropathic pain,如diabetic neuropathy,trigeminal neuralgia,post-herpetic neuralgia等。
  • Diabetic neuropathic pain是臨床上常見之病症,困擾許多DM病人,近年來多種新的anticonvulsants上市,是否也代表治療diabetic neuropathic pain的選擇更多,副作用更少,因此找尋文獻比較各種anticonvulsants對diabetic neuropathic pain的療效。
diabetic peripheral neuropathy
Diabetic peripheral neuropathy
  • 15% DM p’t have S/S of neuropathy
    • DM>25 years affect nearly 50% p’t
  • Pathogenesis: unknown
    • Hyperglycemia
    • Microvascular diasease
  • Treatment: TCAs, NSAID, anticonvulsants, opioids, topical anesthetic agents, nerve block
slide5
期待目標
  • anticonvulsants對diabetic neuropathic pain的治療效果,並找出何種anticonvulsants 是最佳的選擇。
slide6
搜尋步驟
  • 搜尋字串:
    • Neuropathy
    • anticonvulsant, anticonvulsants, carbamazepine, oxcarbazepine, valproate, phenytoin, lamotrigine, vigabatrin, gabapentin, topiramate
    • Clinical trial (PubMed)
  • 搜尋範圍:
    • ACP Journal Club -- 1
    • Cochrane Database of Systematic Reviews -- 1
    • Cochrane Central Register of Controlled Trials, PubMed -- 15
slide8
結果摘要(I)

Cochrane Database of Systematic Reviews

  • Anticonvulsant drugs for acute and chronic pain (2000)
    • Diabetic Neuropathy: Four placebo-controlled studies
      • one with carbamazepine (Rull 1969), two with phenytoin (Chadda 1978, Saudek 1977), and one with gabapentin (Backonja 1998)).
      • Rull (Rull 1969) and Chadda (Chadda 1978) found that with two weeks\' treatment between 30 and 50% more patients improved on anticonvulsant than on placebo.
      • Saudek 1977, using phenytoin (300 mg/day) for 23 weeks of treatment found no difference in mean pain intensity compared with placebo
      • Backonja (Backonja 1998) reported a 60% improvement on a global scale for patients on gabapentin (up to 3.6 grams per day) after four weeks\' treatment in a study of 165 participants.
      • one active control study comparing carbamazepine 200 mg versus a nortriptyline 10 mg/fluphenazine 0.5 mg combination (Gomez -Perez 1996). Only mean data were reported and the authors could not show a difference between the two treatments although it is stated that all patients improved
    • Conclusion: gabapentin is effective in post-herpetic neuralgia and diabetic neuropathy but does not appear to be superior to carbamazepine, a cheaper alternative in many countries. There were, however, no direct comparisons between these two drugs
slide9
結果摘要(II)

ACP journal (2002)

  • Review: Anticonvulsant drugs relieve chronic but not acute pain
    • 6 drugs: carbamazepine (12 trials), phenytoin (6 trials), sodium valproate (2 trials), gabapentin (2 trials), clonazepam (1 trial), and lamotrigine (1 trial)
    • Carbamazepine, phenytoin, and gabapentin were more effective than was placebo in relieving the pain of diabetic neuropathy
    • all caused such minor side effects as drowsiness, dizziness, constipation, nausea, and ataxia (numbers needed to harm [NNHs] ranged from 3 to 4). The NNHs for major harm were not statistically significant for any drug
carbamazepine
結果摘要-Carbamazepine
  • 3 randomized clinical trial
  • 2 with placebo (Rull, 1969; Wilton, 1974)
    • More effective then placebo
  • 1 with nortriptyline and fluphenazine (Gomez-Perez, 1996)
    • Both drugs: improvements from baseline, but no significant difference between 2 drugs
  • Dose: 300-1000mg/d
  • Adverse events (up to 70%): Somnolence, dizziness, gait disturbance
  • Withdrawal rate: 0-7%
phenytoin
結果摘要-Phenytoin
  • 2 randomized clinical trial(Chadda, 1978; Saude, 1977)
  • Conflicting result
sodium valproate
結果摘要-Sodium valproate
  • 2 randomized clinical trial(91 p’t)(Kochar, 2002; 2004)
    • Significant improvement then placebo
      • SF-MPQ: 53.41 (1 month)
      • VAS: 6 3, SF-MPQ: 19.479.66, PPI: 2.711.33 (3 months)
    • Side effect: nausea:2, sedation:1, liver change:2
    • Dose: 1200mg, 1000mg/d
gabapentin i
結果摘要-Gabapentin I
  • 4 randomized clinical trial
    • 3 with placebo, 1 with morphine, 1 with amitriptyline
  • Backonja, 1998 (165p’t)
    • 900 titrated to 3600mg/d
    • Significant pain relief than placebo, improvement of sleep, mood (pain score: 6.43.9; placebo:6.55.1)
    • Pain relief was observed during 2nd week when dose reached 1800mg/d
    • Dizziness 24%, somnolence 23%, headache 11%, diarrhea 11%
  • Gorsen, 1999 (40 p’t)
    • 900mg/d
    • Ineffective at dose of 900mg/d
gabapentin ii
結果摘要-Gabapentin II
  • Morello, 1999 (28 p’t)
    • Gabapentin 900-1800mg, or Amitriptyline 25-75 mg /d
    • No significant different in pain relief
    • No significant difference in occurrence of adverse effects (17 in amitriptyline, 18 in gabapentin)
  • Gilron, 2005 (57p’t)
    • Gabapentin (3200mg), Morphine(120mg), combine(G 2400mg, M 60mg), placebo
    • Gabapentin and Morphine combined achieved better analgesia at lower dose of each drug
    • Adverse effect:
      • Combination: contipation↑than gabapentin, dry mouth↑than morphin
lamotrigine
結果摘要-Lamotrigine
  • 1 randomized clinical trial (53 p’t)(Eisenberg, 2001)
  • Lamotrigine attenuates painful diabetic neuropathy at a daily dose of 200-400mg then placebo (NPS: 6.44.2, MPQ, PDI, BDI: unchanged)
  • Maximal pain reduction:37%, 12 p’t 50% pain reduction
  • Adverse events: similar to placebo (exception 2 rash developed)
topiramate
結果摘要-Topiramate
  • 2 randomized clinical trial
  • Topiramate diabetic neuropathic pain study group, 2004 (3 trial)(1259 p’t)
    • 100mg, 200mg, 300mg
    • 1 effective, 2 no significant (placebo effect high, 38% and 48%)
    • Overall: no significant more effective than placebo
    • 16 ~ 31% discontinuation due to adverse events
  • Raskin, 2004 (12weeks, 323 p’t, 400mg)
    • ½ - 30%, 1/3 - 50% pain reduction
    • Reduced pain and body weight more effective than placebo
    • Adverse event: nausea, somnolence, dizziness, paresthesia, cognition dysfunction, appetite decrease
    • 48% dropout rate
oxcarbazepine
結果摘要-Oxcarbazepine
  • 1 open-label trial (30p’t)(Beydoun, 2004)
    • Significant improvement in total pain score, and present pain intensity (VAS score: 66.334.3, 48.3%)
    • Dose: up to 1200mg/d (mean 814mg)
    • Adverse events(>10%): drowsiness, dizziness, headache, nausea, vomiting, diarrhea
slide19
總結(I)
  • 目前證據顯示carbamazepine, sodium valproate, lamotrigine, gabapentin在治療diabetic neuropathic pain可以顯著改善臨床症狀,但並無試驗直接比較不同anticonvulssants間的差別。
  • Topiramate, phenytoin在不同的臨床試驗出現不同的結果,對於diabetic neuropathic pain的效果尚無定論。
  • Oxcarbazepine, vigabatrin並無RCT來支持治療diabetic neuropathic pain的效果。
  • 新的anticonvulsants (gabapentin, topiramate, oxcarbazepine),仍有許多常見adverse effects如dizziness, somnolence, sedation的作用。
  • Sodium valproate及Lamitrigine的小型試驗中,有較少的副作用。
slide20
總結(II)
  • 對於治療diabetic neuropathic pain,anticonvulsants可以有效減緩疼痛症狀,但需注意治療所引起的不適及副作用。
  • 目前無證據顯示何種anticonvusants為最佳選擇,若考量花費,傳統anticonvulsants仍是優先選擇,若病患不能忍受副作用或是有過敏反應,則可給予不同的anticonvulsants。
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